Dick Chamberlain has a PhD in Statistics and has consulted with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of Computer Systems Validation, computerized project scheduling, strategic planning, quality management, and qualification.He has assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management, Information Quality, and Compliance to Regulations.

• 1 Introduction: The Basics2 Quality Management3 Managing Patient Information4 Applying the Organization to Observation Processes 5 Applying Quality Management to Computers6 The HIMSS-EHR Developer Code of Conduct 7 Developing Standard Operating Procedures (SOPs)8 Compliance9 Conducting Audits10 Risk Management 11 Risk Analysis12 If All Else FailsAppendix A Deming-Key PrinciplesAppendix B FDASIA Health IT ReportAppendix C Sample SOPS

Dick Chamberlain has a PhD in Statistics and has consulted with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of Computer Systems Validation, computerized project scheduling, strategic planning, quality management, and qualification.He has assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management, Information Quality, and Compliance to Regulations.

• 1 Introduction: The Basics2 Quality Management3 Managing Patient Information4 Applying the Organization to Observation Processes 5 Applying Quality Management to Computers6 The HIMSS-EHR Developer Code of Conduct 7 Developing Standard Operating Procedures (SOPs)8 Compliance9 Conducting Audits10 Risk Management 11 Risk Analysis12 If All Else FailsAppendix A Deming-Key PrinciplesAppendix B FDASIA Health IT ReportAppendix C Sample SOPS

Dick Chamberlain has a PhD in Statistics and has consulted with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of Computer Systems Validation, computerized project scheduling, strategic planning, quality management, and qualification.He has assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management, Information Quality, and Compliance to Regulations.

• 1 Introduction: The Basics2 Quality Management3 Managing Patient Information4 Applying the Organization to Observation Processes 5 Applying Quality Management to Computers6 The HIMSS-EHR Developer Code of Conduct 7 Developing Standard Operating Procedures (SOPs)8 Compliance9 Conducting Audits10 Risk Management 11 Risk Analysis12 If All Else FailsAppendix A Deming-Key PrinciplesAppendix B FDASIA Health IT ReportAppendix C Sample SOPS